Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hs-cTn - Optimizing the Diagnosis of Acute Myocardial Infarction/Injury in Women (CODE-MI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03819894
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : February 12, 2020
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
BC Centre for Improved Cardiovascular Health

Brief Summary:
The project is focussed on evaluating the impact of using a female-specific threshold in the diagnosis of myocardial infarction. This female threshold is lower than the overall hs-cTn threshold currently in use. The investigators hypothesize that this change in process, applied at the hospital level, will lead to better assessment, treatment and outcomes of women presenting to the emergency department with chest pain that is cardiac in nature.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Sex Differences High Sensitivity Troponin Diagnostic Test: Introduction of a lower female hs-cTn threshold Not Applicable

Detailed Description:

In subjects with suspected acute coronary syndromes (ACS), females are significantly less likely to undergo investigations, receive evidence-based treatments, and consistently have worse outcomes than males. The gap in outcomes is particularly marked among adults < 55 years of age. Sex differences in symptom presentation and in the diagnostic threshold for cardiac biomarkers have been suggested as reasons for the under-diagnosis and under-treatment of women. Cardiac troponin (cTn) T and I are proteins specific to the myocardium, which with elevated and changing concentrations detected in the blood, along with signs or symptoms consistent with myocardial ischemia, are indicative of a diagnosis of myocardial infarction (MI). With the introduction of high-sensitivity (hs) cTn tests, which allow the detection of very low concentrations of troponin, it has become evident that the level of cTn in a healthy population is approximately two-fold higher in males than in females.

Consequently, the 99th percentile threshold for cTn, the reference value used in diagnosis of MI, is lower in females compared to males. Despite this evidence and recent guidelines recommending the use of sex specific thresholds, a single, overall cTn threshold is still being used for diagnosis of MI, in both men and women, in most clinical settings.

There is mounting evidence from several jurisdictions that the rate of MI is increasing among younger females, and that there is a persistent under-diagnosis, under-treatment, and high risk of adverse outcomes among females, especially younger females, compared to their male counterparts. A better approach to the diagnostic assessment of females presenting to the emergency department (ED) with chest pain is therefore urgently needed. Additionally, several Canadian hospitals have recently made the transition from sensitive to high sensitivity cTn assays, allowing for the examination of subtle but important sex-specific differences in cTn concentrations. With this background, the investigators propose a nationwide, randomized clinical trial (RCT) to determine whether establishing female thresholds results in improved diagnosis and treatment of MI and therefore improved prognosis in women.

To determine whether the use of female hs-cTn thresholds in the assessment of women presenting to the ED with chest pain suggestive of cardiac ischemia, improves diagnostic assessment, treatment and 1-year outcomes. Specifically, the investigators will examine the impact of using female hs-cTn thresholds on:

  • Diagnostic and therapeutic strategies;
  • Prognosis: 1-year all-cause mortality, non-fatal MI, incident heart failure (HF) hospitalization or emergent/urgent coronary revascularization;
  • Costs of diagnostic testing and treatment.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24000 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Stepped-wedge cluster-randomized trial. Unidirectional crossover design where clusters cross over sequentially, in random order, from the control to intervention phase.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Hs-cTn - Optimizing the Diagnosis of Acute Myocardial Infarction/Injury in Women
Actual Study Start Date : February 8, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: Intervention
The intervention is the introduction of a lower female threshold. In cluster-randomized trials, the cluster (i.e., hospital) is the unit of randomization.
Diagnostic Test: Introduction of a lower female hs-cTn threshold
The new female hs-cTn threshold will be baed on current recommendations for each of the assays used (hs-cTn T and I). The hospitals are the unit of randomization. At 5-month intervals, randomly selected hospitals will be advised that they are to transition to the intervention phase. For all men, the standard of care, overall population threshold will be used throughout the entire study.

No Intervention: Control
The control phase will be standard of care, with the use of an overall population hs-cTn T and I threshold, for both men and women, to identify those with myocardial injury/infarction.



Primary Outcome Measures :
  1. Number of patients with all-cause mortality, non-fatal myocardial infarction, hospitalization for incident heart failure, or urgent/emergent coronary revascularization (percutaneous coronary intervention or coronary artery bypass surgery) [ Time Frame: 1-year post index emergency department presentation ]

Secondary Outcome Measures :
  1. Number of patients with a) Non-fatal myocardial infarction or all-cause mortality; b) Urgent/emergent coronary revascularization or all-cause mortality; c) Hospitalization for heart failure or all-cause mortality. [ Time Frame: 1-year post index emergency department presentation ]
  2. Proportion of patients who fill at least one prescription for evidence-based cardiac medications [ Time Frame: Within 90 days of ED visit ]
    Medications include beta-blockers, Angiotensin Converting Enzyme (ACE)-I/Angiotensin II receptor blockers (ARB), statins, anti-platelets

  3. Proportion of patients who undergo diagnostic tests [ Time Frame: Within 90 days of ED visit ]
    Diagnostic tests include nuclear medicine cardiac scan, exercise stress test, diagnostic cardiac catheterization/CT angiogram or echocardiogram



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >20 years of age
  • Present to the ED with chest pain or shortness of breath suggestive of ischemia
  • Have a valid personal health identifier
  • Have 1 hs-cTn test result

Exclusion Criteria:

  • Have ST elevation myocardial infarction (STEMI)
  • Not residents in the same province as the hospital ED to which they present or move out of province within a year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03819894


Contacts
Layout table for location contacts
Contact: Mona Izadnegahdar, PhD 604-6822344 ext 66794 mizadnegahdar@icvhealth.ubc.ca
Contact: Salima Jutha, CCRA 604-806-9119 CodeMI@icvhealth.ubc.ca

Locations
Layout table for location information
Canada, British Columbia
St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada
Contact: Mona Izadnegahdar, PhD       mizadnegahdar@icvhealth.ubc.ca   
Sponsors and Collaborators
BC Centre for Improved Cardiovascular Health
Canadian Institutes of Health Research (CIHR)
Investigators
Layout table for investigator information
Principal Investigator: Karin Humphries, DSc Medicine, Cardiology, UBC, BC Centre for Improved Cardiovascular Health
Layout table for additonal information
Responsible Party: BC Centre for Improved Cardiovascular Health
ClinicalTrials.gov Identifier: NCT03819894    
Other Study ID Numbers: H18-02116
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BC Centre for Improved Cardiovascular Health:
myocardial infarction
sex differences
high-sensitivity cardiac troponin
biomarkers
heart attack
emergency department
acute coronary syndrome
Additional relevant MeSH terms:
Layout table for MeSH terms
Myocardial Infarction
Hypersensitivity
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Immune System Diseases